This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase.

In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually.

In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.

The primary outcome measure is that the 10-year Kaplan-Meier survivorship estimate of the COC 28mm implanted hips will be a minimum of 90% (as recommended by National Institute of Clinical Excellence [NICE]). Based on an anticipated margin of error (ie. one-half the width of the confidence interval) of 7%, the lower 95% confidence interval will be no worse than 83%.

The 28 mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. The Pinnacle acetabular shell is a hemispherical type acetabulum replacement prosthesis, is available in a range of outer diameter (OD) sizes, and is used with a 28mm femoral head. Pinnacle 100 shells will be used in this study. The BIOLOX® delta ceramic femoral head components are manufactured from the same ceramic material as the acetabular bearing insert components. The femoral head is secured to the femoral stem component with an interlocking taper.

Device: Ceramax Acetabular System

28mm Ceramic-on-ceramic Acetabular Cup System

Other Name: Ceramic-on-ceramic 28 mm Acetabular Cup

Detailed Description:

This is a prospective, non-randomized study of the 28mm Ceramic on Ceramic (COC) device. This study will follow each subject through 10 years postoperatively and will consist of:

a clinical follow-up phase and

a clinical outcomes phase.

Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then annually through year 5 for each subject. For years 6 - 10, a communication will be sent to each subject in order to collect survivorship and general health information. This communication will ask whether the COC device is still in vivo and, if not, when the revision surgery took place, why, and which components were removed, if applicable. In addition, subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up interval. A self-addressed, stamped envelope will be provided to facilitate information return and privacy.

Eligibility

Ages Eligible for Study:

Child, Adult, Senior

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Subjects who were previously enrolled in the COC28 IDE study, or

Newly recruited individuals who are qualified based on the approved labeling of the device, and;

Individuals who are willing and able to provide informed patient consent for participation in the study;

Individuals who are willing and able to return for follow-up as specified by the study protocol; and

Individuals who are willing and able to complete the Hip Outcomes questionnaire and SF-12 Health Survey as specified by the study protocol

Exclusion Criteria:

In the opinion of the Investigator, the individual does not qualify based upon approved labeling requirements.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657435